JPH01274765A - Sterilizing agent concentrate injection system - Google Patents

Abstract

PURPOSE: To provide an injecting system for a condensed sterilizer of making possible to guarantee a sterilized state by composing of that a reservoir for housing an ampoule which is sealed and fixed to a bent passage forming a bent-opening at the one end of the reservoir and is provided with the outer wall forming a contents measuring portion mounted at the circumference of bent-opening, and the outlet means of an antimicrobial solution of selectively discharging the antimicrobial solution from the ampoule into water are installed. CONSTITUTION: An amount of liquid sterilizer 96 to be filled up into an ampoule 46 is made so as to become lower the upper surface of a sterilizer than an opening 86 to selectively such the condensed solution of the sterilizer from the ampoule 46 by a sucking device 44. When water flows in from a water container 20, the powder agent of well 34 is dissolved in water. When filling up into system is completed, water is selectively discharged from the water container 20 through the well 34 and the sucking device 44. According to the recirculation of water, the powder agent is dissolved, the sterilizer is sucked from the ampoule 46 and then the sterilizer and the agent are circulated within a conduit system 18. The temperature of solution is controlled by a heating coil 54, and a heated solution is continued to recirculate until the whole exposed surfaces of articles, the interior of container, the conduit system and values are sterilized.

Description

DETAILED DESCRIPTION OF THE INVENTION Field of the Invention The present invention relates to ampoule systems for keeping components, particularly reactive components and drugs, separated until immediately before use. This applies in particular to sterilization systems where buffers, corrosion inhibitors, and peracetic acid disinfectants are diluted and dissolved immediately before the sterilization operation. However, it will be appreciated that the present invention is also useful in other multi-component systems that are mixed during use, such as photographic systems, coating systems, pharmaceuticals, and the like.

BACKGROUND OF THE INVENTION Steam autoclave sterilization systems have traditionally been used in most medical facilities. Typically, medical devices were sent to a central sterilization facility where they were sterilized under the supervision of a sterilization room technician. Steam autoclaves have a 1-2 hour cycle during which the equipment is subjected to high pressure superheated steam. After the appropriate sterilization time, the autoclave was evacuated and cooled.

Equipment that cannot withstand autoclave temperatures generally
It was sterilized with ethylene oxide gas.

After the instruments were placed in the sterilization chamber and sealed, highly toxic ethylene oxide gas was introduced under pressure and held there for a period of 2.3 hours, appropriate for the selected sterilization cycle. After the sterilization cycle was completed, the device could not be used until the ethylene oxide absorbed therein was removed. This removal required about 12-16 hours in vacuum or about 72 hours in air.

Additionally, liquid sterilization systems were available for instruments that could not withstand both autoclaving and ethylene oxide systems. However, most of this was done manually. That is, the instruments were immersed in a vat or tank filled with a stable disinfectant solution, such as hydrogen peroxide or glutaraldehyde. However, liquid systems have been more commonly used for disinfection because sterilization typically requires long soak times of about 6 to 10 hours. Liquid disinfectants or disinfectants are harmful to human tissue, so instruments had to be rinsed before being used on a patient.

Tap water, which is not sterile, was often used as a rinsing agent.

Sterilization refers to the removal of all life forms, including bacterial endospores, which are the most resistant organisms to known disinfectants. In contrast, disinfection refers only to a state in which pathogenic life forms have been removed. As will be understood, disinfection by removing all life forms is easier to demonstrate and control than disinfection by removing only pathogenic life forms rather than all life forms. .

Bacterial spores are the most resistant life form to disinfectants and are therefore commonly used as a stable, renewable indicator of disinfectant efficacy. As a medical sterilizer, its Sterility Assurance Level (SAL) is defined as the probability that an item containing one bacterial spore will be detected is 1.
One in a million or less is generally considered the minimum acceptable level for medical devices. In practice, this level of assurance is achieved by providing an exposure time necessary to kill a predetermined amount of endospores of bacteria known to be resistant to the disinfectant. The rate of spore destruction is generally logarithmic.

The logarithmic failure rate is generally expressed as a value, which allows the exposure time required to achieve a 10-' guarantee level to be easily calculated.

Pathogenic microorganisms are mostly asexual forms of bacteria, which are not stable enough to lead to disinfection or equivalents, so the effectiveness of readily available disinfectants is limited. There are no biologics shown.

In accordance with the present invention, there is provided a new and improved ampoule and reactive agent dispensing system and other devices in which the reactive agent is released upon use, which solves the above-mentioned and similar problems with disinfectants. Ru.

(Means for Solving the Problems) The ampoule of the present invention includes a vent passage in which a vent opening is formed at one end, and is sealed to the vent passage, and is arranged around the vent opening so that the ampoule has an inner capacity. It has an outer wall that forms part of the building.

The ampoule of the invention may further include a gas permeable fluid barrier membrane mounted over the vent opening.

The ampoule of the present invention further comprises a fluid medicament partially filled in the internal volume, wherein the vent opening is located substantially at the center of the volume of the internal volume, and the ampoule further comprises a fluid medicament partially filled in the internal volume. may be located below the vent opening, regardless of the direction of the ampoule, and gas may be released from the internal volume while liquid drug may be retained.

The ampoule of the present invention is characterized in that the vent passageway is linear and has a relatively small diameter, and for a hollow tunnel passing through the vent opening along the vent passageway for aspirating liquid from the ampoule. The position of the vent opening may prevent liquid held in the ampoule from exiting the ampoule after the tube has been pulled up.

The ampoules of the present invention include an outer cup partially filled with peracetic acid and having a vent opening and containing a powdered medicament containing at least one of a buffering agent, a detergent, and a corrosion inhibitor. It may be placed inside.

The microbial decontamination system of the present invention comprises a water supply, a container for holding the items to be microbially decontaminated, and a conduit system providing a fluid flow path for water from the water supply to flow into the container. , a vent passage into which a powdered chemical containing at least one of a buffering agent, a cleaning agent, and a corrosion inhibitor is introduced, and a vent opening is formed at one end, and the vent passage is sealed. containing a vented ampoule having an outer wall disposed around said vent opening and defining an inner volume filled with less than half of its volume with an antimicrobial solution; a storage tank connected to the conduit system such that the powdered drug is dissolved by incoming water; and an antibacterial tank for selectively discharging the antibacterial solution from the ampoule into the water. Equipped with solution discharge means.

The microbial decontamination system of the present invention may further include a gas permeable fluid barrier membrane mounted over the vent opening.

In the microbial decontamination system of the present invention, the vent opening is arranged substantially at the geometric center of the internal volume, and the upper surface of the antibacterial solution is below the vent opening regardless of the direction of the ampoule. Position 17 may be continued, thereby allowing gas to be released from the internal volume but retaining the antimicrobial solution.

In the microbial decontamination system of the present invention, the antibacterial solution may contain peracetic acid.

In the microbial decontamination system of the present invention, the conduit system comprises:
After the conduit system and the container have been filled with water, a valve is provided to prevent further water from entering, and a water-containing valve is provided to ensure that both the container and the conduit system are microbiologically decontaminated. a pump connected to the conduit system for circulating the antimicrobial solution within the conduit system and container, and selectively removes antimicrobial solution and powder drug residues from the items undergoing microbial decontamination; further comprising means for supplying a sterile rinsing liquid to the conduit system for rinsing, such that the conduit system is microbially decontaminated such that the sterile rinsing liquid flows into the container; Ensures flow only along surfaces that have been microbially decontaminated, thereby ensuring that microbially decontaminated items are not contaminated with bacteria from the conduit system. You can.

In one aspect of the invention, a vented ampoule is provided that is configured to prevent leakage. The vent passage has a vent opening formed at one end thereof.

The internal capacity is made up of a sealed outer wall.
The interior volume is disposed about the vent opening such that the vent opening is substantially centered within the interior volume. The outer wall is sealed to the vent passage so that the vent opening is the only access to the inner volume.

According to a more limited aspect of the invention, a gas permeable fluid barrier membrane is mounted over the vent opening. In this way, gas is released from the internal volume, but fluid leakage is prevented. The ampoule contains less than half its volume of liquid drug.

The amount of liquid is selected such that the top surface of the liquid is below the vent opening no matter what orientation the ampoule is in.

In another aspect of the invention, a siphon suction system is provided for aspirating liquid from the ampoule. A small diameter tubular member passes through the vent passageway and extends into the interior volume. The tubular member is connected to an aspirator for aspirating liquid from the ampoule and mixing it with the second medicament. In a preferred embodiment, the first agent is a concentrated disinfectant concentrate, such as peracetic acid, and the second agent is a diluting solvent, such as water.

In another more limited aspect of the invention, the water and the aspirated disinfectant concentrate are connected to a container holding the items to be disinfected and a conduit connecting the container to a source of sterile rinse water. The product is circulated through the system, and this circulation continues until the item, the interior of the container, and the conduit system are all sterilized. In this way, during the rinse time of the sterilization cycle, the sterile rinse solution cannot transport bacterial contaminants from the conduit into contact with sterilized items.

One of the advantages of the present invention is that it provides a sterilization system that ensures sterility.

Another advantage of the present invention is that a bulk dose disinfectant cartridge is provided to ensure proper formulation of the drug and eliminate operator error.

Yet another advantage of the present invention is that it provides a vented liquid holding ampoule that exhibits no liquid leakage in any orientation.

In addition, "mlcrobial decontamination"
"amination" means at least sterilization.
ilization and disinfection
on).

Further advantages of the present invention will become apparent upon reading and understanding the following detailed description.

(Example) The present invention can be embodied as various parts and configurations of these parts, or various steps and configurations of these steps. The accompanying drawings are for the purpose of illustrating preferred embodiments only and are not intended to limit the invention.

In FIGS. 1 and 2, a dilution solvent or water source 10
The water or other fluid agent is supplied by the pump. In a preferred embodiment of the sterilizer, the sailor supply includes a conduit 12 connected to a water faucet or other plumbing fixture, and a regulating valve 14 for selectively injecting and shutting off water to the water sterilization means 16. It is equipped with In a preferred embodiment, the water disinfection means is a filter that removes particles the same size or larger than bacteria.

The filter is connected by a conduit system to a container or module 20 for containing the items to be sterilized. In a preferred embodiment, the container is constituted by a removable tray 22 configured to accommodate the item to be sterilized, such as an endoscope. Lid 24
is sealed to the tray by an elastic gasket 26, thereby completing the container. Transparent window 2 on the lid
8 can also be provided.

During the fill cycle, sterile water flows through the conduit system and fills the container 20. Water enters the container and drug receiving well 34 via spray nozzle 30 and container diffusion manifold 32 . As the amount of incoming water increases, vent line 36 fills with excess water and is discharged to drain pipe 40 via check valve 38.

A drug introduction system 42 selectively adds disinfectants, buffers, detergents, and corrosion inhibitors to the diluent solvent.

More specifically, the sterilant concentrate is selectively aspirated from the ampoule 46 by the aspirator 44 . As water flows from the container, the powdered drug contained in the well 34 dissolves.

Once the system has been filled, water is selectively evacuated from the container 20 via the well 34 and the suction device 44 by the pump 5o. Recirculation of water dissolves the powdered drug, draws the disinfectant from the ampoule, and circulates the disinfectant and drug within the conduit system 18. Preferably, the vent line 36 is very short in length and has a fairly large diameter so that the solution circulates along the entire exposed portion of the drain check valve 38 and vent check valve 52. A heating coil 54 regulates the temperature of the solution. The recirculation continues until all exposed surfaces of the item, the interior of the container, and the conduit system and valves are sterilized.

As the disinfectant solution is drained through the drain valve 56,
Sterile air is supplied into the system through air sterilization means, preferably a filter that removes particles the same size or larger than bacteria. The fill valve 14 is then opened and the discharge valve 56 is closed. The sterile filter 16 thereby becomes a source of sterile rinsing fluid. Note that sterility is ensured since the sterile rinse fluid flows only along sterile surfaces. pump 5
0 causes the sterile rinse solution to circulate through the system. The sterile rinse fluid is drained by reopening drain valve 56. When the valve 6o is closed, the pump 50
It functions to send the liquid to the discharge pipe 4o and discharge it out of the system. Still other drain lines (not shown) and aspirators or pumps (not shown) may be provided to remove liquid from all areas of the system.

In particular, in FIG. 3, the sterilant aspirator system 42 comprises a hollow tubular needle or tube 7o that is inserted into the ampoule to aspirate the sterilant. The needle 70
is connected to an arm 72 that swings the needle into and out of alignment with ampoule 46. Vertical tubular section 74 is nested within stationary tubular section 76 . The arm tubular part is
It is biased upward by the coil spring 78, which causes the
Needle 70 is removed from the ampoule. Once the arm is secured in proper alignment with the ampoule, closing the lid 24 forces the arm downwardly and compresses the coil spring 78, which forces the needle 70 into the ampoule.

The water injected through the aspirator 44 draws the disinfectant from the ampoule and expels it in the fluid flow. Preferably, the suction speed is selected such that the disinfectant is gradually suctioned over the time required for one cycle through the system.

In FIGS. 4A, 4B, and 4C, the disinfectant ampoule 46 has an outer wall 80 defining an internal volume portion 82 therein.
It is equipped with A linear vent passage 84 that is integral with the outer wall defines a passage extending linearly from the outer wall to the vent opening 86. In the preferred embodiment, the vent passageway extends linearly along the first axis 88 and serves as a guide for the needle 70. In this manner, the needle 70 is inserted into the contents via the vent opening 86.

In the illustrated embodiment, the outer wall includes an annular cylindrical peripheral wall 90 at a minimum radius r from the first axis.

End walls 92 and 94 extend generally transversely to axis 88;
The tube is integrally sealed with the peripheral wall. The vent opening 86 is located at the center of the capacitor. More specifically, vent opening 86 is located at a minimum radius r from the peripheral wall and approximately a height h from each end wall. The amount of fluid sterilant 96 filled into the ampoule is determined by
below the vent opening 86, less than half its capacity. More specifically, the internal volume portion 82 is formed to correspond to the amount of disinfectant, so that the depth of the disinfectant is always below h and r regardless of the orientation of the ampoule. . In this manner, no matter how ampoule 46 is oriented, liquid will not escape from vent opening 86.

A porous membrane 100 is used to prevent liquid from splashing and leaking.
is located above the vent opening 86. The membrane is composed of a fine textile material, has intermediate pores that are sufficiently small in size compared to water droplets, and has a hygroscopic effect or surface tension of the disinfectant on the fiber material, so that the disinfectant Passage through the membrane is effectively blocked. It is likewise prevented that water flows freely into the ampoule. As the needle 70 passes through the vent opening 86, the beveled end deforms the woven porous material and moves the fibers to allow the needle to pass. When the needle is pulled up, the natural elasticity of the fibers tends to return it to its original position.

The disinfectant residue is retained within the ampoule at the vent opening 86 and membrane 1oo. In this way, the operator does not have direct contact with the full strength disinfectant concentrate after the disinfection cycle is complete. Similarly, if the disinfection cycle is stopped before aspiration begins, the disinfectant concentrate will not be diluted.

Referring again to FIG. 1, and particularly to FIGS. 5A-5D, in operation, ampoule 46 is placed in the bottom of a larger transparent container 110. The container 110 is provided with a peel top 112 to allow access to the contents. The shape of the container is such that the ampoule 46 fits into its bottom and the other powdered drug 114 is placed on top.

In FIG. 5B, the sterilizer arm 72 is rotated to open the passageway and inject the powder into the well 34. Ampoule 46 is held in place within the well by rod or other ampoule support means 116. In the illustrated embodiment, the symmetrical shape of the ampoule ensures that the vent opening 86 is centrally located. Alternatively, the support means 116 may be provided with a key or key means for cooperating with a predetermined portion of the ampoule to ensure proper alignment and placement.

In FIG. 5C, aspirator arm 72 is rotated and secured once needle 70 is positioned directly above vent opening 86. In FIG. Because the ampoule is precisely placed within the well, the aspirator arm is automatically aligned and secured without manual intervention by the operator. When the lid 24 is closed as shown in FIG. 5D, it cams the aspirator arm against the coil spring 78 and the tip of the needle 70 passes through the vent opening to the proper position within the ampoule. inserted. The ampoule may also be provided with a small well in direct alignment with the vent to accommodate the tip of the aspirator needle and allow for more complete emptying of the ampoule.

In a preferred embodiment, the powder material includes a buffering agent, a detergent, and a corrosion inhibitor. The corrosion inhibitor is selected depending on the disinfectant selected and the nature of the material of the item to be sterilized, such as brass-type fixtures, which can corrode. Further describing the preferred embodiment, peracetic acid is used as the disinfectant.

Peracetic acid has a tendency to liberate small amounts of oxygen during transport and storage. Thus, the vent 86 prevents the pressure within the ampoule from building up and causing the ampoule to burst. Further, if the pressure is high, the sterilizer may be dispersed when the needle 70 is inserted. Once peracetic acid is diluted and mixed with buffers, detergents, and corrosion inhibitors, it loses its effectiveness as a disinfectant in a relatively short period of time. The rate of loss of potency is very slow compared to normal sterilization cycles, but if the ampoule contains all ingredients, the loss is short and the ampoule retains sufficient shelf life. I can't.

As shown in FIGS. 6, 7, and 8, the ampoule can have a variety of shapes. For example, as shown in FIG. 6, the outer wall 80 may have a spherical shape. The vent opening is again located in the center of the sphere and the filling level is such that the depth of the disinfectant is below the radius of the spherical inner volume. Alternatively, the vent openings may be arranged eccentrically, as shown in FIG. However, the vent opening is located sufficiently close to the center of the interior volume so that the top surface of the disinfectant in the dish being dispensed is always located below the vent opening. Further alternatively, as shown in FIG. 8, the ampoule may include a groove or keyway 120 in the outer wall or in the outer flange to ensure that the ampoule is placed in a predetermined alignment position. A groove or opening 122 may be provided.

A sufficiently unique or special external shape or key shape is selected to prevent the insertion of substantially cylindrical ampoules of other devices that may contain substances other than disinfectants. can be prevented.

In FIG. 9, disinfectants, buffers, detergents, corrosion inhibitors, and other agents may be recovered from the two-compartment container in other ways. For example, a liquid-filled ampoule 46 may be attached to the top of a transparent plastic cup 110 containing a powdered ingredient or drug 114. The powder component is selected to contain materials that change color when exposed to the liquid component. In this way, it is visually confirmed that the liquid component has not leaked into the powder component. A vent 124 in the outer cup provides communication between the ampoule and the atmosphere. Rather than siphoning liquid disinfectant, a first hole in the bottom of the cup allows a ram 130 to be inserted;
This injects water or other diluting solvent into the cup;
The powder drug is dissolved. The cup is cut by the first cutter 132 so that more water can be injected into the cup as water pumped into the well circulates within the powder region of the cup. Another cutter 134 penetrates both the cup and the sterilant ampoule.

In this way, the powder component can be dissolved and mixed with circulating water or other diluent solvent before the disinfectant is released.

In the illustrated embodiment, the cutters 132 and 134
are attached to a common shaft 136 that rotates incrementally so that the cups and ampoules are cut in stages.

Although the invention has been described in terms of preferred embodiments, alterations and modifications will become apparent to others upon reading and understanding the foregoing detailed description. It is intended that the invention cover all such changes and modifications insofar as they come within the scope of the appended claims or their equivalents.

4. No! I FIG. 1 is a perspective view of a sterilization device according to the invention.

FIG. 2 is a piping diagram of the sterilizer of FIG. 1.

FIG. 3 is a detailed cross-sectional view of the aspirator disinfectant suction assembly of FIG. 1;

4A, 4B, and 4C are cross-sectional views showing details of the ampoule of FIG. 3 in various directions.

Figures 5A, 5B, 5C, and 5D are illustrations showing a preferred method of filling the sterilizer with disinfectant and powdered chemicals.

FIG. 6 is a cross-sectional view of another embodiment of the disinfectant ampoule of the present invention.

FIG. 7 is a cross-sectional view of yet another embodiment of a disinfectant ampoule.

FIG. 8 is a plan view of an embodiment of a disinfectant ampoule and pond.

FIG. 9 is an explanatory diagram of another drug release device.

12... Conduit, 20... Container, 34... Well, 44... Aspirator, 46... Ampoule, 72...
- Arm, 86...Vent opening, 100...Porous membrane.

Shi- FIG.8

Claims (1)

[Claims] 1. A vent passage having a vent opening formed at one end, and an outer wall that is sealed to the vent passage and arranged around the vent opening to constitute an inner volume portion. , an ampoule containing. 2. The ampoule of claim 1 further comprising a gas permeable fluid barrier membrane mounted over the vent opening. 3. The vent opening is located substantially at the center of the volume of the internal volume, further comprising a fluid medicament partially filled in the internal volume, the fluid medicament being above the ampoule. 2. The ampoule of claim 1, wherein the ampoule is positioned below the vent opening regardless of orientation so that gas is released from the internal volume while liquid medicament is retained. 4. The vent passageway is linear and has a relatively small diameter and acts as a guide for a hollow tube passing along the vent passageway and through the vent opening in order to aspirate liquid from the ampoule. 2. The ampoule of claim 1, wherein the location of the vent opening prevents liquid retained in the ampoule from exiting the ampoule after the tube is withdrawn. 5. disposed in an outer cup partially filled with peracetic acid and containing a powdered medicament having a vent opening and containing at least one of a buffering agent, a detergent, and a corrosion inhibitor; The ampoule according to claim 1, wherein the ampoule is 6. A microbial decontamination system comprising: a water supply, a container for holding the items to be subjected to microbial decontamination, and a conduit providing a fluid flow path for water from the water supply to flow into the container. at least one of a system, a buffer, a cleaning agent, and a corrosion inhibitor.
a vent passage, in which a powder medicine containing a type of powder is introduced, and a vent opening is formed at one end; A storage tank for receiving a vented ampoule having an outer wall defining an inner volume filled with less than half the volume of an antimicrobial solution, the powdered drug being dissolved by the inflowing water. a storage tank connected to said conduit system so as to allow said microbial decontamination system, and an antimicrobial solution discharge means for selectively discharging said antimicrobial solution from said ampoule into water. 7. The system of claim 6, further comprising a gas permeable fluid barrier membrane mounted over the vent opening. 8. the vent opening is located substantially at the geometric center of the internal volume such that the top surface of the antimicrobial solution remains below the vent opening regardless of the orientation of the ampoule; 7. The system of claim 6, wherein gas is released from the internal volume while retaining the antimicrobial solution. 9. The system of claim 6, wherein the antimicrobial solution contains peracetic acid. 10. The conduit system is provided with a valve to prevent further water from entering after the conduit system and the container are filled with water, and a microbial decontamination of both the container and the conduit system. a pump connected to the conduit system for circulating a water-containing antimicrobial solution within the conduit system and container, and also removes the antimicrobial solution and powdered drug from the item undergoing microbial decontamination. further comprising means for supplying a sterile rinsing liquid to the conduit system for selectively rinsing off residues of the sterile rinsing liquid, such that the conduit system is microbially decontaminated so that the sterile rinsing liquid flows into the container. ensuring that the rinsing fluid flows only along surfaces that have been microbially decontaminated, thereby preventing contamination of microbially decontaminated items with bacteria from the conduit system; Claim 6
system described in.